IQPP Standard for Recording Donor Adverse Events - Version 2.0 Implemented April 1, 2018 - Plasma Protein ...
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IQPP Standard for Recording
Donor Adverse Events
Version 2.0
Implemented April 1, 2018Background
The IQPP Standard for Recording Donor Adverse Events is part of a series of
standards that comprise the Plasma Protein Therapeutics Association (PPTA) IQPP
Standards Program. PPTA's Voluntary Standards Program provides global
leadership for the plasma protein industry's goal of continuous improvement with a
focus on safety and quality from the donor to the patient.
This voluntary IQPP Standard was developed by the PPTA IQPP Standards
Committee, and was approved by the PPTA Source Board of Directors on February
8, 2018. This version supersedes version 1.0 in its entirety.
For questions about this PPTA Voluntary Standard contact IQPP@pptaglobal.org.
For more information about the IQPP Standards Program or PPTA, visit
www.pptaglobal.org.
©2018 by the Plasma Protein Therapeutics Association
PPTA
147 Old Solomons lsland Road, Suite 100
Annapolis, Maryland 21401
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018IQPP Standard for Recording Donor Adverse Events
Version 2.0
1. Introduction
In 2006, the United States Federal Advisory Committee for Blood Safety and Availability
(“Committee”) recommended that the federal government engage in efforts to enhance
safety monitoring for blood products, cell and tissue products and solid organs in
partnership with private sector initiatives. 1 These monitoring systems, collectively
termed “biovigilance,” were viewed by the committee as important tools for improving
outcomes related to transfusion and transplantation therapy. Donor biovigilance is
integral to the total biovigilance program since donors provide the "raw materials" for
biologic treatments, and because safety of living donors is a related and important
public health issue.2
All IQPP certified establishments have processes in place to monitor, manage, and
document donor adverse events. This IQPP Standard serves as the foundation for
establishing industry-wide requirements for adverse event definitions and classification.
This Standard is part of a series of standards that comprise the PPTA IQPP Voluntary
Standards Program. For more information about the program, visit www.pptaglobal.org.
2. Scope
This standard applies to facilities that collect Source Plasma.
3. Terms and Definitions
3.1. BP
blood pressure
3.2. DAE
donor adverse event
3.3. LOC
loss of consciousness
1
Letter dated February 9, 2007, from Chair, ACBSA, to ASH John O. Agwunobi, https://wayback.archive-
it.org/3919/20140402193410/http://www.hhs.gov/ash/bloodsafety/advisorycommittee/recommendations/recomm
endations200608.pdf
2
Biovigilance in the United States: Efforts to Bridge A Critical Gap in Patient Safety and Donor Health,
report of PHS Biovigilance Task Group in Response to HHS ACBSA recommendations,
https://www.researchgate.net/profile/James_Bowman3/publication/255703308_Biovigilance_in_the_United_Stat
es_Efforts_to_Bridge_a_Critical_Gap_in_Patient_Safety_and_Donor_Health/links/56b0c3d608ae8e372151f08a/
Biovigilance-in-the-United-States-Efforts-to-Bridge-a-Critical-Gap-in-Patient-Safety-and-Donor-Health.pdf
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 20184. Requirements
4.1. General
Companies shall have a documented process for recording known DAEs considered to
be associated with any part of a Source Plasma donation program (this includes initial
screening, donation, immunization for high titer collections, etc.) following company
approved SOPs.
NOTE: The presence of an isolated sign/symptom/finding in Attachment A does not
necessarily require the recording of a DAE if not associated with the
donation/immunization process. Similarly, equipment issues (e.g. RBC spill, machine
malfunction, AC run out) in the absence of associated donor signs/symptoms/findings,
does not require recording of a DAE.
All DAEs listed in the DAE Classifications in Subclause 4.2 which have an asterisk (*)
shall be classified in accordance with this IQPP Standard by a licensed physician or
physician substitute utilizing the available information and best medical judgment.
Each DAE shall be assigned to a single category using the DAE Classifications list in
Subclause 4.2. If the donor subsequently returns to the center with symptoms of
another event, unrelated to the original DAE, the new event can be recorded and
classified as a separate event but linked to the same donation. For example, on
5/10/2016, a new donor experiences a Hypotensive Event with LOC of less than 60
seconds. The donor returns to the center on 5/11/2016 exhibiting a large hematoma at
the venipuncture site from the 5/10/2016 donation. These events may be recorded as
separate DAEs linked to the 5/10/2016 donation.
All DAEs listed in the DAE Classifications list in Subclause 4.2 which do not have an
asterisk (*) shall be managed according to company SOPs and are not subject to
tracking and trending under this Standard.
DAEs, when occurring off-site and reported to the facility, shall be documented
including whatever information is available, with the understanding that the information
may be limited and not completely accurate.
Companies shall follow Attachment A, Donor Adverse Event Classification Guide, when
reviewing and classifying each event in their process.
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 20184.2. DAE Classifications
DAEs include the following:
Recording
Category Requirement Sub-Category
(* = record)
Hypotensive Event
(vasovagal/Hypovolemia)
Prefaint, No LOC (Minor)
* Prefaint, No LOC (Moderate)
* LOC approximately less than 60 Seconds
* LOC approximately 60 Seconds or longer
* Severe (With or Without LOC)
* Injury
Major Cardiovascular or Respiratory
*
Event
Local Injury Related to Phlebotomy
Event
* Nerve Irritation
Hematoma/Bruise (Uncomplicated)
* Hematoma/Bruise (Complicated)
* Infection
* Arterial Puncture
Infiltration
* Major Blood Vessel Injury
Citrate Reaction Event
Minor
* Moderate
* Severe
Hemolysis/Hemoglobinuria Event
* Uncomplicated
* Complicated
Air Embolus Event
Uncomplicated
* Complicated
Allergic Event
* Local
* Generalized
* Anaphylaxis
Hyperventilation Event *
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018Recording
Category Requirement Sub-Category
(* = record)
Immunization Event
Local, mild
* Local, severe
Systemic, mild
* Systemic, severe
* Hypotensive, no LOC
* Hypotensive, LOC
Other Event *
4.3. Donor Variables
The DAE recording process shall incorporate the following variables in accordance with
company SOPs:
a) The donor’s age
b) The donor’s gender
c) The donor’s weight
d) The donor’s height
e) The date of donation (mm/dd/yyyy)
f) The time of donation (military or standard) (This is the time of venipuncture.)
g) The name and title of the staff member recording the reaction
h) The pre-donation Diastolic BP
i) The pre-donation Systolic BP
j) The pre-donation pulse
k) The timing when the reaction was first known to begin, either:
o Pre-donation;
o During Donation;
o Post-donation on-site;
o Post-donation off-site;
o Immunization – immediate (less than or equal to 15 minutes after immunization);
or
o Immunization – delayed (more than 15 minutes after immunization)
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018l) Special observation relating to the donor reaction event (when applicable):
o Collected volume at the time of the DAE
m) Transport and/or hospitalization within 24 hours
4.4. Inspection and Compliance Verification
At the Corporate Audit, inspectors shall request the company SOPs related to DAE
recording, and review the company’s documented process for recording known DAEs.
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018ATTACHMENT A – Donor Adverse Event Classification Guide
DAE Classification Description Signs/Symptoms/Findings
1. Hypotensive (Vasovagal/Hypovolemia)
Hypotensive reaction (vasovagal/hypovolemia) that falls into any of the following categories.
NOTE: For the purposes of this IQPP Standard, “medical staff intervention” means the use of expertise from the physician or
physician substitute to make decisions regarding management of the DAE.
1.1 Hypotensive: Prefaint, No LOC This reaction: May include one or more of the following:
(Minor) a. must resolve without medical staff a. Abdominal cramps;
(e.g., physician substitute) b. Auditory disturbance (e.g. sounds coming
intervention, AND from a distance or “buzzing” in the ears);
b. Involves signs and symptoms that c. Chills or Shivering;
resolved quickly (e.g. within d. Clammy;
approximately 10 minutes). e. Cold extremities;
f. Dizziness;
g. Epigastric discomfort;
h. Facial pallor (e.g. pale skin or lips);
i. Feeling of Warmth;
j. Headache or neck ache;
k. Hypotension;
l. Lightheadedness;
m. Nausea;
n. Palpitations;
o. Sweating;
p. Visual Disturbance (e.g. blurred or faded
vision); or
q. Weakness.
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018DAE Classification Description Signs/Symptoms/Findings
1.2 Hypotensive: Prefaint, No LOC This reaction: May include any in 1.1 AND
(Moderate): a. requires medical staff (physician a. Vomiting.
substitute) intervention, OR
b. involves signs/symptoms that did not
resolve quickly (e.g. within
approximately 10 minutes), OR
c. additional signs/symptoms may be
present.
1.3 Hypotensive: LOC (brief) In this reaction, LOC lasts approximately May include any in 1.1 or 1.2.
less than sixty seconds.
1.4 Hypotensive: LOC (prolonged) In this reaction, LOC lasts approximately May include any in 1.1 or 1.2.
sixty seconds or longer.
1.5 Hypotensive; Severe (With or This reaction may or may not include May include any in 1.1 through 1.4 AND any of
Without LOC): LOC. the following:
a. Chest Pain;
b. Convulsions/Seizures
c. Loss of Bladder/Bowel Control; or
d. Prolonged signs or symptoms that do not
resolve.
1.6 Hypotensive; Injury A hypotensive event that results in ANY May include any of 1.1 – 1.5 as well as any
type of injury such as: signs/symptoms related to the injury itself.
a. Closed Head Injury;
b. Dental Injury;
c. Fracture;
d. Laceration;
e. Soft Tissue Injury (not phlebotomy-
related); or
f. Other.
NOTE: If the donor exhibits symptoms of a hypotensive event (1.1 through 1.6), in addition to “anxiety,” then the event should be
classified according to “1.1 – 1.6 Hypotensive.”
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018DAE Classification Description Signs/Symptoms/Findings
2. Major Cardiovascular or Respiratory Event
Major cardiovascular or respiratory event that occurs within 24 hours of the completion of donation and which falls into the
following.
2.1 Major Cardiovascular or Major cardiovascular or respiratory event May include any of the below:
Respiratory Event that occurs within 24 hours of the a. Angina Pectoris;
completion of donation. b. Cardiac Arrest;
c. Cerebrovascular Accident;
d. Myocardial Infarction;
e. Transient Ischemic Attack; or
f. Respiratory Arrest.
3. Local Injury Related to Phlebotomy
Local injury related to phlebotomy that falls into one of the following categories.
3.1 Local Injury Related to Persistent signs, symptoms, or findings in May include any of the below:
Phlebotomy: Nerve Irritation a peripheral nerve distribution associated a. Immediate Intense Pain at Site;
with the venipuncture area, which began b. Paresthesias, Numbness/Tingling of
at venipuncture or later (in the absence of Fingers, Hand, or Arm;
a visible hematoma). c. Shooting Pain Down Arm; or
d. Weakness of Arm.
3.2 Local Injury Related to A hematoma/bruise that is approximately May include any of the below:
Phlebotomy: Hematoma/Bruise ≤ 2” x 2.” a. Mild Pain;
(uncomplicated) b. No Restriction of Movement;
"≤ 2" x 2"" means that both dimensions c. Skin Discoloration; or
are ≤ 2". For example, a d. Swelling.
hematoma/bruise that is 2" x 2", in the
absence of signs/symptoms/findings for
"complicated," would be classified as
"uncomplicated." However, a
hematoma/bruise that is 3" x 1", would be
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018DAE Classification Description Signs/Symptoms/Findings
classified as "complicated." If, following
initial classification and prior to resolution,
the hematoma/bruise is found to meet the
classification requirements for
"complicated," then it shall be reclassified
as "complicated" and/or recorded
appropriately in the facility's DAE
documentation system.
3.3 Local Injury Related to A hematoma/bruise that is approximately May include any of the below:
Phlebotomy: Hematoma/Bruise >2” x 2.” a. Paresthesias, Numbness/Tingling of
(complicated) Fingers, Hand, or Arm;
"(>2" x 2")" means that at least one b. Pressure;
dimension is >2". For example, a c. Redness;
hematoma/bruise that is 3" x 2" would be d. Restricted Movement;
classified as "complicated." However, a e. Shooting Pain Down Arm;
hematoma/bruise that is 2" x 1", would be f. Significant Pain;
g. Skin Discoloration;
classified as "uncomplicated, unless also
h. Swelling;
has signs/symptoms/findings for
i. Tenderness;
"complicated." j. Warmth; or
k. Weakness of Arm.
3.4 Local Injury Related to May include any of the below:
Phlebotomy: Infection a. Drainage;
b. Pain;
c. Redness;
d. Swelling;
e. Tenderness; or
f. Warmth.
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018DAE Classification Description Signs/Symptoms/Findings
3.5 Local Injury Related to An apparent arterial puncture May include any of the below:
Phlebotomy: Arterial Puncture a. Bright Red Blood;
b. Pulse Sensation in Tubing; or
c. Pulsing Blood Flow.
3.6 Local Injury Related to An apparent infiltration in the absence of May include any of the below:
Phlebotomy: Infiltration bruising or hematoma a. Pain; or
b. Swelling.
3.7 Local Injury Related to May include any of the below:
Phlebotomy: Major Blood a. Arteriovenous Fistula;
Vessel Injury b. Brachial Artery Pseudoaneurysm;
c. Compartment Syndrome;
d. Venous Thrombosis;
e. Phlebitis; or
f. Thrombophlebitis.
4. Citrate Reaction
Citrate reaction that falls into one of the following
categories.
4.1 Citrate Reaction: Minor Resolves quickly with or without reducing May include any of the below:
flow rate or providing calcium. a. Metallic Taste;
b. Paresthesia (Perioral – Lips
Tingling/Numbness); or
c. Paresthesia (Peripheral - Hands/Feet
Tingling/Numbness).
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018DAE Classification Description Signs/Symptoms/Findings
4.2 Citrate Reaction: Moderate Any of 4.1 that progress to the rest of the body
AND any of the below:
a. Carpopedal Spasms;
b. Chest Pressure;
c. Cold Extremities;
d. Chills/Shivering;
e. Muscle Tightness and/or Cramping;
f. Nausea;
g. Pallor, Pale Skin or Lips;
h. Shortness of Breath;
i. Sneezing/Nasal Congestion;
j. Tetany (Transient);
k. Tremors (Sensation of Vibration);
l. Twitching; or
m. Vomiting.
4.3 Citrate Reaction: Severe Any of 4.1 or 4.2 that progress to the rest of the
body AND any of the below:
a. Bluish Tint to Skin (Cyanosis);
b. Chest Pain;
c. Heart Arrhythmia;
d. Hypotension (Severe);
e. Incontinence;
f. Mental Confusion; or
g. Tetany (Severe).
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 20185. Hemolysis/Hemoglobinuria
Reaction that falls into one of the following categories.
5.1 Hemolysis/ Hemoglobinuria: Red/brown colored urine as the only sign
Uncomplicated
5.2 Hemolysis/ Hemoglobinuria: Red/brown colored urine and any of the below:
Complicated a. Back/Flank Pain;
b. Bluish Tint to Skin (Cyanosis);
c. Mental Confusion;
d. Pallor, Pale Skin or Lips; or
e. Shortness of Breath.
6. Air Embolus
Air embolus that falls into one of the following categories.
6.1 Air Embolus: Uncomplicated None
6.2 Air Embolus: Complicated May include any of the below:
a. Back/Flank Pain;
b. Bluish Tint to Skin (Cyanosis);
c. Chest Pain;
d. Mental Confusion;
e. Nausea;
f. Shock;
g. Shortness of breath; or
h. Vomiting.
7. Allergic
Allergic reaction that falls into one of the following categories.
7.1 Allergic: Local In the antecubital area. May include any of the below:
a. Itching;
b. Rash/Hives; or
c. Redness.
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018DAE Classification Description Signs/Symptoms/Findings
7.2 Allergic: Generalized May include any of 7.1 AND any of the below:
a. Itching, Generalized;
b. Rash/Hives, Generalized; or
c. Sneezing/Nasal Congestion.
7.3 Allergic: Anaphylaxis May include any of 7.1 AND any of 7.2 AND any
of the below:
a. Anxiety;
b. Arrhythmia;
c. Bluish Tint to Skin (Cyanosis);
d. Gastrointestinal Symptoms;
e. Laryngeal Edema with Stridor;
f. Restlessness
g. Scratchy Feeling in Throat;
h. Shortness of Breath;
i. Swollen Tongue, Throat, Eyes, and Face;
j. Wheezing; or
k. Hypotension.
NOTE: The term, “Anxiety,” as used here,
includes significant anxiety and is more than
simply being “tense” or verbalizing nervous
feelings a new donor may report, such as
nervousness about:
needles;
blood;
pain or discomfort;
fainting;
being deferred; or
medical environments.
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 20188. Hyperventilation
Hyperventilation that results in any of the following signs and
symptoms.
8.1 Hyperventilation This reaction: May include any of the below:
Is more than simply being “tense” or a. Anxiousness / Anxiety;[3]
verbalizing anxious feelings a donor b. Carpopedal Spasms;
may report, such as nervous about:
c. Chest Tightness;
- Needles;
- Blood; d. Dry Mouth;
- Pain or discomfort; e. Paresthesia (Perioral -
- Fainting; Tingling/Numbness);
- Being deferred; or f. Paresthesia (Peripheral - Hands/Feet);
- General environment. g. Respiration, Rapid;
Requires medical staff (physician
h. Restlessness;
substitute) intervention, OR
Involves signs/symptoms that do not i. Shaking;
resolve quickly with supportive care j. Shortness of Breath; or
and reassurance (e.g. within 10 k. Tetany.
minutes)
[3]If the donor exhibits significant anxiety only resulting from hyperventilation, then classify the event as “8.1 Hyperventilation.”
If the donor exhibits symptom(s) of “8.1 Hyperventilation” and another event (e.g. citrate), then classify the DAE as the other
event.
9. Other
Reaction that does not fall into any other category listed above or in section 10.
9.1 Other A reaction that does not fall into any other Any
category listed above
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018DAE Classification Description Signs/Symptoms/Findings
10. Immunization
Immunization reaction that falls into one of the following categories.
10.1 Immunization: Local, mild Associated with the site of injection May include any of the below:
a. Induration (hardening);
b. Itching;
c. Nodule formation;
d. Pain;
e. Rash;
f. Redness;
g. Swelling;
h. Tenderness; or
i. Urticaria.
10.2 Immunization: Local, severe Associated with the site of injection May include any of 10.1 AND any of the below:
a. Brachial Neuritis;
b. Infection; or
c. Necrosis
10.3 Immunization: Systemic, mild May include any of the below:
a. Arthralgia;
b. Diarrhea;
c. Dizziness;
d. Fatigue;
e. Fever;
f. Flu-like symptoms;
g. Headache;
h. Lymphadenopathy (enlarged, sometimes
tender lymph glands);
i. Malaise;
j. Myalgia (muscular pain);
k. Nausea;
l. Rash, disseminated, diffuse; or
m. Vomiting
IQPP Standard for Recording Donor Adverse Events
Version 2.0
Implemented April 1, 2018DAE Classification Description Signs/Symptoms/Findings
10.4 Immunization: Systemic, Includes specific reactions related to May include any of 10.3 AND any of the below:
severe administration of the vaccine or antigen a. Anaphylaxis or anaphylactoid reactions;
and the complications that may result as b. Hemolytic transfusion reaction (when
well as life threatening reactions. human red blood cells are used as the
Immediate medical care is necessary. antigen); or
c. Serum sickness
See package insert for information on adverse
reactions specific to vaccine administered.
10.5 Immunization: Hypotensive Onset of symptoms considered to be May include any of 1.1 and 1.2
(no LOC) related to an immunization
10.6 Immunization: Hypotensive Onset of symptoms considered to be May include any of 1.3 and 1.4
(LOC) related to an immunization
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Version 2.0
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